This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.
Why Should You Attend:
This presentation will provide an understanding of what the current guidance documents suggest you include in supplier agreements. Quality Assurance (QA) agreements are usually more flexible than standard supplier agreements and can therefore be more detailed and easier to modify than standard supplier contracts which often require legal, as well as management approval. QA agreements with your suppliers can be the easiest way to assure both your company and auditors that you have sufficient control of your key and critical suppliers. QA agreements give details of who is responsible for what between you and your supplier. Yet, because these agreements are detailed and specific to a particular supplier, they should only be used for those suppliers where they provide value.
Areas Covered in the Seminar:
- The types of suppliers that should have QA Agreements to assure FDA and ISO 13485 compliance.
- Explanation, and use of the Global harmonization Task Force s (GHTF) and NBOC supplier guidance documents to create QA agreements.
- How to create supplier QA agreements and the best way to implement them.
- Definition of and requirements for Critical suppliers.
- Supplier agreements best practices.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in
- Quality Management
- Regulatory Affairs
- Supply-chain Management
- Supplier engineering
- Purchasing Management
- Supplier auditing
Added by complianceonlinecom on November 7, 2012